Neck PainNCT03507920
The Effects of Spinal Mobilizations on Neck Pain and Sympathetic Nervous System Activity in People With Neck Pain
A study testing Neck passive mobilizations and Manual contact in people with Neck Pain, run by King's College London at 1 site in Spain.
Trial summary
This study investigates the effects of spinal mobilizations on neck symptoms and sympathetic nervous system activity in people with neck pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- Neck passive mobilizations and Manual contact
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteSpain
- Study dates
- 2 Apr 2018to 2 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary complaint of neck pain
- Non-traumatic history of onset
- Pain has a clear mechanical aggravating and easing positions or movements
- Limited range of motion
- Local provocation tests produce recognisable symptoms
- A positive expectation that mobilisations will help
Who cannot join
- No neurological deficit
- No signs of central hyperexcitability
- Referral to other health professional to exclude red flags not required
Trial locations and contacts
1 site in 1 country.
Spain1 site
University of the Basque Country, Faculty of Medicine and Infirmary
Leioa, Bizkaia, 48940
About this study
This study investigates the effects of spinal mobilizations on neck symptoms and sympathetic nervous system activity in people with neck pain.
- Conditions
- Neck Pain
- Being tested
- Neck passive mobilizations, Manual contact
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck passive mobilizationsOther
Passive mobilizations performed to the neck of the participant by a Physiotherapist
Manual contactOther
Manual contact applied to the neck of the participant by a Physiotherapist
| Study group | Role | What they receive |
|---|---|---|
| Neck passive mobilizations | Experimental | Not described Receives: Other: Neck passive mobilizations |
| Manual contact | Placebo comparator | Not described Receives: Other: Manual contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global rating of change scale
Measures overall improvement as perceived by the participant. It is a 15-point scale ranging from -7 (a very great deal worse), through 0 (no change), to +7 (a great deal better). Values above 0 denote improvement following treatment, 0 denotes no change, and values below 0 denote worsening after the treatment. The higher the value, the greater the improvement; the lower the value, the greater the worsening. The participant will be asked to provide a value that represents their change (they may give 0, which denotes no change) following the intervention.
Measured: Immediately after the intervention
Change in pain reported by the participant during neck movements
The participant will be asked to report if he/she has pain on each of the following movements: flexion, extension, side flexion and rotation
Measured: Baseline and immediately after the intervention
Change in Sympathetic nervous system activity using skin conductance
Skin conductance in the index and ring finger will be measured
Measured: Baseline, during the intervention and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study start2 Apr 2018
- Primary completion2 Jul 2018
- Study completion2 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507920
- Sponsor's protocol ID
- M10/2016/095
- Status last verified
- Apr 2018
- First submitted
- 9 Apr 2018
- Last updated
- 3 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Spinal Mobilizations on Neck Pain and Sympathetic Nervous System Activity in People With Neck Pain
- ClinicalTrials.gov ID
- NCT03507920
- Acronym / sponsor ID
- M10/2016/095
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of the Basque Country (UPV/EHU)
- Study start
- 2 Apr 2018 (actual)
- Primary completion
- 2 Jul 2018 (actual)
- Study completion
- 2 Jul 2018 (actual)
- First posted
- 25 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study investigates the effects of spinal mobilizations on neck symptoms and sympathetic nervous system activity in people with neck pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neck passive mobilizations | Experimental | Other: Neck passive mobilizations |
| Manual contact | Placebo comparator | Other: Manual contact |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Primary complaint of neck pain
- Non-traumatic history of onset
- Pain has a clear mechanical aggravating and easing positions or movements
- Limited range of motion
- Local provocation tests produce recognisable symptoms
Key exclusion criteria (3 listed)
- No neurological deficit
- No signs of central hyperexcitability
- Referral to other health professional to exclude red flags not required
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neck passive mobilizationsPassive mobilizations performed to the neck of the participant by a Physiotherapist | Other | Neck passive mobilizations |
| Manual contactManual contact applied to the neck of the participant by a Physiotherapist | Other | Manual contact |
Primary outcome
Global rating of change scale
Time frame: Immediately after the intervention
Measures overall improvement as perceived by the participant. It is a 15-point scale ranging from -7 (a very great deal worse), through 0 (no change), to +7 (a great deal better). Values above 0 denote improvement following treatment, 0 denotes no change, and values below 0 denote worsening after the treatment. The higher the value, the greater the improvement; the lower the value, the greater the worsening. The participant will be asked to provide a value that represents their change (they may give 0, which denotes no change) following the intervention.
Change in pain reported by the participant during neck movements
Time frame: Baseline and immediately after the intervention
The participant will be asked to report if he/she has pain on each of the following movements: flexion, extension, side flexion and rotation
Change in Sympathetic nervous system activity using skin conductance
Time frame: Baseline, during the intervention and immediately after the intervention
Skin conductance in the index and ring finger will be measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neck passive mobilizations and Manual contact in people with Neck Pain, run by King's College London at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global rating of change scale (time frame: Immediately after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2018.